JP2018134344A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device that treats lymphedema and can reduce a relapse rate after the treatment.SOLUTION: A medical device 10 has: a tube member 300 having a first end 310 connected to a first biological lumen L and a second end 320 connected to a second biological lumen P; and a pumping part 400 for pumping a body fluid in the first biological lumen to the second biological lumen.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a medical device used for the treatment of lymphedema.

  Lymphedema is a disease that develops due to the local accumulation of lymph outside the lymphatic vessels due to the stagnation of the flow of lymph flowing through the lymphatic vessels present in the living body.

  Lymphedema treatment methods include, for example, pressure therapy to relieve symptoms by attaching a medical device that applies compression to each part of the body that has been swollen by lymphedema, and a drug that has a therapeutic effect on lymphedema Pharmacotherapy (see Patent Document 1 below), vein-lymphatic anastomosis (LVA), in which the vein and lymphatic vessel are anastomosed (bypassed) by surgical treatment and the lymph fluid is allowed to flow into the vein Lymphaticovenous anatomosis) and the like are known. Among these treatment methods, venous-lymphatic anastomosis has attracted attention in recent years because it has a very high therapeutic effect in the early stage of developing lymphedema.

Special table 2009-544339

  However, in the venous-lymphatic anastomosis as described above, if time passes after the operation, the veins and lymphatic vessels used for the venous-lymphatic anastomosis are clogged with impurities, blood clots, etc. Lymphedema may recur due to stagnation of lymph flow. For this reason, the obstruction rate of lymphatic vessels after venous-lymphatic anastomosis is as high as 60% two years after the operation. When lymphedema recurred, it was necessary to find a lymphatic vessel different from the lymphatic vessel used for venous-lymphatic anastomosis and perform venous-lymphatic anastomosis again.

  The present invention has been made in view of the above problems, and an object of the present invention is to provide a medical device that can treat lymphedema and reduce the recurrence rate after the treatment.

  A medical device according to the present invention includes a tube member including a first end connected to a first living body lumen, and a second end connected to the first living body lumen, and the first living body lumen. And a pumping unit that pumps the body fluid into the second living body lumen.

  According to the medical device of the present invention, the first biological lumen (lymph vessel) and the second biological lumen (vein) are connected via the tube member, and the body fluid in the first biological lumen is transmitted by the pumping unit. By sending (lymph fluid) to the second living body lumen, body fluid can be forcibly sent. In addition, a substance that causes clogging can be forced to flow by periodically pumping body fluid in the first living body lumen to the second living body lumen by the pumping unit. As a result, lymphedema can be treated and the recurrence rate after the treatment of lymphedema can be reduced.

It is the schematic which shows the whole structure of the medical device which concerns on 1st Embodiment. It is a side view of the indwelling needle concerning a 1st embodiment. It is an expanded sectional view of the indwelling needle concerning a 1st embodiment. It is a figure which shows each procedure of the procedure using the medical device which concerns on 1st Embodiment. FIGS. 5A and 5B are diagrams showing an example of a technique for lymphedema. FIGS. 6A and 6B are cross-sectional views schematically showing an example of a technique using the indwelling needle according to the first embodiment. It is a perspective view of the medical device which concerns on 2nd Embodiment. It is sectional drawing of the medical device which concerns on 2nd Embodiment. 9A and 9B are cross-sectional views schematically showing an example of a technique using the medical instrument according to the second embodiment. FIGS. 10A and 10B are cross-sectional views schematically showing a procedure example using the medical instrument according to the second embodiment. FIGS. 11A and 11B are cross-sectional views schematically showing a procedure example using the medical instrument according to the second embodiment.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

<First Embodiment>
FIG. 1 is a schematic diagram illustrating the overall configuration of the medical device 10 according to the first embodiment, FIG. 2 is a side view of the first indwelling needle 100, and FIG. 2 is an enlarged cross-sectional view of an indwelling needle 100. FIG.

  The medical device 10 according to the present embodiment makes it possible to treat lymphedema and prevent recurrence by forcing the lymph fluid from the lymphatic vessel L to the vein P of a patient suffering from lymphedema. It is configured as a medical device for the treatment of lymphedema.

  As shown in FIG. 1, the medical device 10 generally includes a first indwelling needle 100 including a first catheter unit 110 placed in a lymph vessel L (corresponding to a first biological lumen), and a vein P (second A second indwelling needle 200 including a second catheter part 210 that is punctured and indwelled in the body lumen), a tube member 300 that connects the first catheter part 110 and the second catheter part 210, and a tube member 300 And a pump 400 (corresponding to a pressure-feeding part) for pumping lymph fluid (corresponding to body fluid) in the lymph vessel L to the vein P via the.

(Indwelling needle 100, 200)
The first indwelling needle 100 and the second indwelling needle 200 will be described. In the present specification, the first indwelling needle 100 and the second indwelling needle 200 are collectively referred to as an indwelling needle.

  As shown in FIG. 1, the first indwelling needle 100 is punctured into the lymph vessel L in a state where the first indwelling needle 100 is disposed in the lumen of the first catheter unit 110 and the first catheter unit 110 (see FIG. 2). An inner needle 120 having a needle tip 121, an inner needle hub 130 attached to the proximal end side of the inner needle 120, and a grip 140 connected to the proximal end side of the inner needle hub 130.

  In the description of the first indwelling needle 100 and the second indwelling needle 200, the side where the inner needles 120 and 220 are punctured into the lymphatic vessel L and the vein P (the lower side in FIG. 2) is referred to as the distal end side and is grasped. The side on which the parts 140 and 240 are arranged (the upper side in FIG. 2) is referred to as a base end side.

  The first indwelling needle 100 is configured such that the first catheter portion 110 can be separated from other components (the inner needle 120, the inner needle hub 130, and the grip portion 140). As a result, the first indwelling needle 100 is punctured into the lymphatic vessel L in the assembled state as shown in FIG. 6A, and only the first catheter unit 110 is inserted into the lymphatic vessel as shown in FIG. 6B. L can be placed.

  The first catheter portion 110 has a lumen, and includes a sheath 111 placed in the lymph vessel L and a catheter hub 112 attached to the proximal end side of the sheath 111.

  It is preferable that the sheath 111 has flexibility and is wholly or partially transparent. Since all or part of the sheath 111 is transparent, it can be visually confirmed that body fluid such as blood or lymph has flowed into the sheath 111.

  The catheter hub 112 is configured to be connectable to a first end portion 310 of a tube member 300 described later. The catheter hub 112 is configured so that the sheath 111 and the tube member 300 can be connected in a liquid-tight manner in a state where the first end portion 310 of the tube member 300 is connected.

  As shown in FIGS. 2 and 3, in the inner needle 120, the needle tip 121 at the distal end protrudes further toward the distal end side than the sheath 111 in a state of being inserted through the lumen of the sheath 111. In this state, the distal end of the sheath 111 is disposed in the vicinity of the distal end of the inner needle 120. Thus, when the distal end of the inner needle 120 is inserted into the lymphatic vessel L, the sheath 111 is also inserted into the same lymphatic vessel L.

  As shown in FIG. 1, the second indwelling needle 200 includes a second catheter unit 210, an inner needle 220 having a needle tip that can puncture the vein P, and an inner needle attached to the proximal end side of the inner needle 220. It has a hub 230 and a grip portion 240 connected to the proximal end side of the inner needle hub 230. In addition, since the 2nd indwelling needle 200 has the structure substantially the same as the 1st indwelling needle 100, illustration corresponding to FIG. 2, FIG. 3 of the 1st indwelling needle 100 is abbreviate | omitted.

  The second catheter section 210 has a lumen, and has a sheath 211 placed in the vein P and a catheter hub 212 attached to the proximal end side of the sheath 211.

  The catheter hub 212 is configured to be connectable to a second end 320 of a tube member 300 described later. The catheter hub 212 is configured so that the sheath 211 and the tube member 300 can be connected in a liquid-tight manner in a state where the second end portion 320 of the tube member 300 is connected.

  The constituent material of the sheaths 111 and 211 is not particularly limited. For example, polyolefin such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer, polyolefin elastomer, polyvinyl chloride, polyester, polyester elastomer, polyether nylon, polyamide, Polyamide elastomer, polyurethane, polyurethane elastomer, polystyrene, polyacetal, polycarbonate, polymethyl methacrylate and other methacrylic resins, polyvinyl alcohol, polysulfone, polyimide, polyetherimide, polyethersulfone, polyetheretherketone, polybutadiene, ethylene-tetrafluoroethylene, etc. At least one selected from the group consisting of a fluororesin and a silicone resin Butter, and the like. In addition, the said resin may be used individually by 1 type, or may be used in the form of a mixture of 2 or more types. In addition, in order to improve the slidability with respect to the inner wall of the lymph vessel L and the vein P, a hydrophilic coat may be applied to the outer surfaces of the sheaths 111 and 211.

  The outer diameter of the sheaths 111 and 211 can be appropriately selected according to the outer diameter of the lymph vessel L or vein P to be treated, but is preferably formed to be 0.8 mm or less, for example. When the outer diameters of the lymph vessels L and veins P are about 1 mm, the outer diameter of the sheath 111 can be about 0.7 mm. By setting the outer diameters of the sheaths 111 and 211 as described above, a less invasive procedure can be performed. The inner diameters of the sheaths 111 and 211 are preferably 0.35 mm or more. By setting the inner diameters of the sheaths 111 and 211 as described above, it is possible to ensure the flow rate of the lymph fluid to be sent and to quickly treat lymphedema.

(Tube member 300)
As shown in FIG. 1, the tube member 300 includes a first end 310 connected to the lymphatic vessel L via the first catheter part 110 and a second end connected to the vein P via the second catheter part 210. And an end portion 320. A pump 400 is disposed between the first end 310 and the second end 320 of the tube member 300.

  Although the outer diameter of the tube member 300 is not specifically limited, For example, it can form in 0.8 mm or less.

  Since the lymph fluid flowing in the tube member 300 has a very high protein concentration, the tube member 300 may be clogged when adsorbed on the inner surface of the tube member 300 in a large amount. For this reason, it is preferable to form an adhesion preventing surface with a coating or the like that prevents adhesion of proteins or the like on the inner surface of the tube member 300.

  Anti-adhesion surfaces, for example, hydrophilic coatings, fluorine-based coatings, silicon-based coatings, surfaces with fine concavo-convex structures, and surfaces that combine the above coatings with concavo-convex structures, and do not mix with blood such as silicon oil or fluorinated oil It can be configured by forming a surface or the like for holding a stable liquid phase at an arbitrary position of the tube member 300.

  In addition, since the inner surface of the tube member 300 may come into contact with blood, it is preferable to apply various coatings. For example, it is possible to mix an antithrombotic substance in the material constituting the tube member 300, or to coat the inner surface of the tube member 300 with the antithrombotic substance. In particular, since the second end portion 320 is highly likely to come into contact with blood in the vein P, antithrombotic properties are added to the inner surface of the second end portion 320 in order to prevent thrombus and the like from attaching. It is preferable.

  As the antithrombotic substance, heparin, heparin-like substance, PMEA (poly (2 methoxyethyl acrylate)), PEG (polyethylene glycol), betaine zwitterionic polymer, and the like can be used.

(Pump 400)
The pump 400 incorporates a part of the tube member 300, presses the outer peripheral surface of the tube member 300 with a plurality of fingers (not shown), and swings the tube member 300 to remove the lymph fluid in the lymph vessel L. A peristaltic pump mechanism for pumping to the vein P is provided.

  The pump mechanism is, for example, a lymph fluid at an appropriate flow rate by moving each finger forward and backward in a predetermined cycle with respect to the tube member 300 in conjunction with a rotating operation of a camshaft (not shown) having a plurality of eccentric cams. Can be configured to be capable of feeding liquid. More specifically, after releasing the pressure by the fingers arranged on the upstream side in the direction of lymph fluid delivery and allowing the lymph fluid to flow into the tube member 300, each finger moves the tube member 300 toward the lymph fluid delivery direction. The lymph fluid can be sent out by sequentially pressing and deforming so as to perform a peristaltic motion. By providing such a peristaltic pump mechanism, the pump 400 is configured to be able to adjust the flow rate of the lymph fluid to be fed.

  Next, with reference to FIGS. 4-6, the usage example of the medical device 10 which concerns on this embodiment is demonstrated.

  FIG. 4 is a diagram showing each procedure of a procedure using the medical device 10, FIG. 5 is a diagram showing a procedure example of lymphedema, and FIG. 6 is a diagram schematically showing a procedure example using the first indwelling needle 100. It is sectional drawing.

  Referring to FIG. 4, the method for treating lymphedema can be summarized as follows: a specifying step (S11) for specifying lymphatic vessel L to be treated, and an exposing step (S12) for exposing lymphatic vessel L by incising the skin. A first indwelling step (S13) in which the first indwelling needle 100 is punctured into the lymph vessel L and the first catheter unit 110 is indwelled, and the first catheter unit 110 and the first end 310 of the tube member 300 are connected. A first connecting step (S14), a second indwelling step (S15) in which the second indwelling needle 200 is punctured into the vein P and the second catheter unit 210 is indwelled, and the second catheter unit 210 and the tube member 300 A second connection step (S16) for connecting the two end portions 320 and a liquid feeding step (S17) for feeding the lymph fluid from the lymph vessel L to the vein P using the pump 400 are included. Hereinafter, each step will be described.

  First, a specific process (S11) is performed.

  In the specifying step (S11), the lymph vessel L to be treated is specified. As a specific method, for example, ICG (Indocyanine green) fluorescent lymphangiography can be used. FIG. 5 (A) schematically shows a state in which lymphatic vessels L are visualized by ICG fluorescent lymphangiography.

  In the ICG fluorescence lymphangiography, ICG contrast agent is injected into several affected lower limbs and upper limbs, and the flow in the lymph vessel L is visualized by using a known infrared camera. And the arbitrary lymphatic vessel L is specified as a treatment object among the lymphatic vessels L where the flow of the ICG contrast agent is stagnant. For example, when treating lymphedema of the lower limbs, lymphatic vessels L existing on the back of the foot, ankle, lower leg, above the knee, below the knee, etc. can be selected as a treatment target, and when treating lymphedema of the upper limb, Lymphatic vessels L present around the wrist, forearm, elbow, etc. can be selected as a treatment target.

  In addition, as the lymphatic vessel L, for example, a shallow lymphatic vessel that exists directly under the skin S can be selected. The outer diameter of the selected lymphatic vessel L is preferably, for example, 1 mm or more. In addition, after the exposure process (S12) described later, the outer diameter of the lymph vessel L may be expanded by stimulating the lymph vessel L.

  Next, an exposure step (S12) is performed.

  In the exposure step (S12), as shown in FIG. 5 (B), the skin S covering the lymphatic vessel L specified as the treatment target is incised to form an incision d, and the lymphatic vessel L is exposed. The incision can be performed using a known treatment tool such as a scalpel.

  Next, a 1st indwelling process (S13) is performed.

  The first indwelling step (S13) can be performed using the first indwelling needle 100.

  In starting the first indwelling step (S13), as shown in FIG. 2, the first indwelling needle 100 integrates the first catheter part 110, the inner needle 120, the inner needle hub 130, and the gripping part 140 together. Prepare in the assembled state.

  Next, as shown in FIG. 6A, the inner needle 120 of the first indwelling needle 100 is punctured into the lymph vessel L. By causing the needle tip 121 of the inner needle 120 to penetrate the tube wall L1 of the lymph vessel L, a puncture site (perforation) t is formed in the tube wall L1, and at the same time, the distal end portion of the sheath 111 is inserted into the puncture site t. Let Thereafter, as shown in FIG. 6B, the inner needle 120, the inner needle hub 130, and the grasping portion 140 are removed, and only the first catheter portion 110 is placed in the lymph vessel L.

  Next, a 1st connection process (S14) is performed.

  In the first connection step (S14), the first end portion 310 of the tube member 300 is connected to the catheter hub 112 of the first catheter portion 110 as shown in FIG. Thereby, the 1st catheter part 110 and the tube member 300 are connected fluid-tightly.

  Next, a second indwelling step (S15) is performed.

  The second indwelling step (S15) can be performed using the second indwelling needle 200.

  In starting the second indwelling step (S15), the second indwelling needle 200 is similar to the first indwelling step (S13) in that each of the second catheter part 210, the inner needle 220, the inner needle hub 230, and the grasping part 240 is used. Prepare with the unit assembled.

  Next, in the second indwelling step (S15), the inner needle 220 of the second indwelling needle 200 is punctured percutaneously into the vein P. Thereafter, the inner needle 220, the inner needle hub 230, and the grip portion 240 are removed, and only the second catheter portion 210 is placed in the vein P. Since the second indwelling step (S15) is the same as the first indwelling step (S13), the illustration is omitted.

  Next, a second connection step (S16) is performed.

  In the second connection step (S16), the second end portion 320 of the tube member 300 is connected to the catheter hub 212 of the second catheter portion 210 as shown in FIG. Thereby, the 2nd catheter part 210 and the tube member 300 are connected fluid-tightly.

  The second indwelling step (S15) and the second connecting step (S16) may be performed prior to the first indwelling step (S13) and the first connecting step (S14). In addition, after the first indwelling step (S13) and the second indwelling step (S15) are performed first, the first connecting step (S14) and the second connecting step (S16) may be performed.

  Next, a liquid feeding process (S17) is performed.

  In the liquid feeding step (S17), the pump 400 is operated to deliver the lymph fluid from the lymph vessel L side to the vein P side (in the arrow direction in FIG. 1) via the tube member 300. This eliminates the retention of lymph that causes lymphedema, alleviates symptoms such as swelling in the affected area, and completes the treatment of lymphedema.

  In the liquid feeding step (S17), the flow rate (liquid feeding amount) of the lymph fluid fed by the pump 400 varies depending on the sizes of the lymphatic vessels L and veins P, but can be set to 100 mL / h, for example. Further, the time for feeding the liquid by the pump 400 can be set to about 1 to 24 hours, for example.

  After the treatment of lymphedema, the above lymphedema treatment steps (S11 to S17) are periodically repeated. Thereby, before the lymphatic vessel L and vein P are clogged and lymphedema recurs, impurities such as cholesterol and substances that cause clogging such as blood clots can be forced to flow. As a result, the recurrence rate after treatment of lymphedema can be reduced. The frequency of performing the lymphedema treatment step (S11 to S17) after the treatment of lymphedema can be, for example, once every three months or once every six months.

  In the above usage example, the example in which the lymph fluid is sent from one lymph vessel L to the vein P has been described, but the lymph fluid may be sent from a plurality of lymph vessels L to the vein P. Even in this case, the same procedure as in the above use example can be performed. In addition, it is preferable to change the flow volume of the lymph to send according to the number of lymphatic vessels. For example, when the lymph fluid is sent from the two lymph vessels L to the vein P, the flow rate of the lymph fluid fed by the pump 400 can be set to about twice (for example, 200 mL / h) of the above use example. preferable.

  As described above, the medical device 10 according to this embodiment includes the first end 310 connected to the lymphatic vessel L (first biological lumen) and the second end connected to the vein P (second biological lumen). A tube member 300 having an end portion 320; and a pump 400 (pumping portion) for pumping lymph fluid (body fluid) in the lymph vessel L to the vein P.

  According to the medical device 10 configured as described above, the lymph vessel L and the vein P are connected via the tube member 300, and the lymph fluid in the lymph vessel L is pumped to the vein P by the pump 400, whereby the lymph fluid is The liquid can be forcibly sent. Further, by periodically pumping the lymph in the lymph vessel L to the vein P by the pump 400, impurities such as cholesterol and substances that cause clogging such as blood clots can be forced to flow. As a result, lymphedema can be treated and the recurrence rate after the treatment of lymphedema can be reduced.

  In addition, the pump 400 includes a peristaltic pump mechanism that perturbs the tube member 300 and pressure-feeds the lymph in the lymph vessel L to the veins P, so that the lymph can be forcibly fed and sent. The flow rate of lymph can be adjusted.

  In addition, the medical device 10 is placed in the lymph vessel L, the first catheter unit 110 that connects the lymph vessel L and the first end 310 of the tube member 300, and the vein P, And a second catheter portion 210 that connects the vein P and the second end portion 320 of the tube member 300. Via the first catheter part 110 and the second catheter part 210, the first end part 310 and the second end part 320 of the tube member 300 can be connected to the lymph vessel L and the vein P relatively easily. it can.

  The medical device 10 also includes a first indwelling needle 100 that includes a first catheter unit 110 and an inner needle 120 that is punctured into the lymphatic vessel L while being disposed in the lumen of the first catheter unit 110. And a second catheter portion 210 and a second indwelling needle 200 including an inner needle 220 that is punctured into the vein P while being disposed in the lumen of the second catheter portion 210. Yes. Thereby, the procedure of placing the first catheter unit 110 with respect to the lymph vessel L and the procedure of placing the second catheter unit 210 with respect to the vein P can be performed relatively easily.

Second Embodiment
Next, a medical device according to the second embodiment will be described with reference to FIGS. In addition, about the structure similar to 1st Embodiment mentioned above, the same code | symbol is attached | subjected and the description is abbreviate | omitted. Further, points not particularly mentioned in the second embodiment can be configured in the same manner as in the first embodiment described above.

  7 is a schematic perspective view of the medical device 500, FIG. 8 is a cross-sectional view of the medical device 500 taken along line 8-8 shown in FIG. 7, and FIGS. 9 to 11 illustrate a procedure example using the medical device 500. It is a figure for doing.

  In the first embodiment described above, the first catheter portion 110 is placed in the lymph vessel L using the first indwelling needle 100. However, in this embodiment, the first catheter portion 110a is placed in the lymph vessel L using the medical instrument 500. It differs in that it is placed in the tube L. Other configurations are the same as those of the first embodiment described above.

  The medical device according to the second embodiment includes a second indwelling needle 200 including a medical instrument 500 for indwelling the first catheter unit 110a in the lymph vessel L and a second catheter unit 210 that is punctured and indwelled in the vein P. A tube member 300a that connects the first catheter part 110a and the second catheter part 210, and a pump 400 that pumps the lymph fluid in the lymph vessel L to the vein P via the tube member 300a.

(First catheter portion 110a)
As shown in FIG. 11B, the first catheter portion 110a according to the present embodiment is a female connector that can be connected in a state where the first end portion 310a of the tube member 300a corresponding to a male connector is inserted into the lumen. It is configured.

  At the proximal end portion of the first catheter portion 110a, a removal preventing portion 113a for preventing the removal from the puncture site t formed in the lymph vessel L is provided. The slip-off preventing portion 113a is configured by a convex portion having a shape protruding outward in the radial direction. As shown in FIG. 11 (A), the disconnection preventing portion 113a is disposed in the lymph vessel L in a state where the first catheter portion 110a is inserted into the puncture site t formed in the lymph vessel L.

  The slip-out preventing portion 113a is used when the force in the direction of slipping out from the puncture site t (upward force in FIG. 11A) acts on the first catheter portion 110a inadvertently. Is brought into contact with the inner surface of the tube wall L1 of the lymph vessel L. Due to this contact, the slip-out preventing portion 113a applies a locking force that prevents the first catheter portion 110a from slipping out of the lymph vessel L. Thus, by providing the first catheter part 110a with the drop prevention part 113a, it is possible to more stably maintain the state in which the first catheter part 110a is fixed to the lymph vessel L. It should be noted that the shape of the omission prevention portion 113a is not limited to the illustrated shape, and can be changed as appropriate.

  As shown to FIG. 11 (A), the 1st catheter part 110a has the concave fitting part 114a in the inner surface. The first end portion 310a of the tube member 300a has a convex fitting portion 311a that can be fitted to the fitting portion 114a of the first catheter portion 110a on the outer surface thereof. As shown in FIG. 11B, by inserting the first end portion 310a into the first catheter portion 110a and fitting the fitting portions 114a and 311a with each other, the first catheter portion 110a, the tube member 300a, Can be prevented from being inadvertently released.

(Medical device 500)
As shown in FIGS. 7 and 8, the medical device 500 includes a puncture member 510 having a lumen that can accommodate the first catheter portion 110a and having a needle tip 511 that can puncture the lymph vessel L, and puncture. The pusher 520 for operating the movement of the first catheter portion 110a accommodated in the member 510, the outer tube 530 disposed so as to cover the outer periphery of the puncture member 510, and the puncture member 510 are punctured into the lymph vessel L At this time, a negative pressure generating section 540 that generates a negative pressure for deforming the tube wall L1 of the lymphatic vessel L toward the puncture member 510 is provided.

  In the description of the medical device 500, the side of the puncture member 510 where the needle tip 511 is formed (the lower side in FIG. 8) is the tip side, and the side opposite to the side where the needle tip 511 of the puncture member 510 is formed ( The upper side in FIG. 8 is referred to as the proximal end side.

  The puncture member 510 is constituted by a hollow member. In addition, the puncture member 510 forms a needle tip 511 that can puncture the lymphatic vessel L at the tip thereof.

  The puncture member 510 can be made of, for example, a known resin material or metal material having biocompatibility. Further, the puncture member 510 is preferably configured to have a predetermined hardness so that the puncture property of the needle tip 511 is ensured to some extent. Examples of the constituent material of the puncture member 510 include polypropylene, polyethylene, polyethylene terephthalate, polymethyl methacrylate, polycarbonate, polyether ether ketone, polyether ketone ketone, polytetrafluoroethylene, and tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer. , Tetrafluoroethylene / hexafluoropropylene copolymer, tetrafluoroethylene / ethylene copolymer, PVDF (polyvinylidene fluoride, polychlorotrifluoroethylene, chlorotrifluoroethylene / ethylene copolymer, UV curable resin, etc.) , SUS, NiTi, CoCr, and other metal materials, glass, ceramics, etc. The puncture member 510 is made of a resin material. That case, in order to improve the efficiency of the procedure as a visible internal piercing member 510 from the outside, it is preferable to form the piercing member 510 transparent or translucent.

  As shown in FIG. 8, the pusher 520 includes a rod-shaped main body portion 521 and a push-in portion 522 that is disposed at the distal end of the main body portion 521 and applies a pressing force that moves the first catheter portion 110a to the distal end side. I have. A user (operator or the like) who uses the medical device 10 moves the first catheter portion 110a forward to the distal end side of the puncture member 510 by holding the main body portion 521 with fingers and moving the pusher 520 forward. Thus, an operation of pushing out the first catheter portion 110a from the lumen 510a of the puncture member 510 can be performed.

  The negative pressure generation unit 540 is configured by a piston that generates a negative pressure in the lumen 510a of the puncture member 510. Specifically, the negative pressure generating portion 540 has a rod-like main body portion 541 inserted into the lumen 510a of the puncture member 510, and a valve body (plunger) 542 provided at the tip of the main body portion 541. ing. The valve body 542 of the negative pressure generating unit 540 is slidably inserted into the lumen 510 a of the puncture member 510.

  As shown in FIG. 9A, when using the negative pressure generating portion 540, the outer cylinder 530 covers the outer peripheral surface of the puncture member 510, and the distal opening of the outer cylinder 530 is connected to the lymph vessel L. An airtight space g is defined around the puncture member 510 by being disposed so as to be in contact with the outer surface of the tube wall L1.

  When the valve body 542 of the negative pressure generating portion 540 is slid toward the proximal end side of the puncture member 510 as shown in FIG. 9B with the space g divided by the outer cylinder 530, the puncture member 510 is interposed. Thus, a suction pressure acts on the space part g, and a negative pressure (negative pressure) is generated in the space part g. As a result, the tube wall L1 of the lymph vessel L is lifted and deformed so that the tube wall L1 approaches the needle tip 511 side of the puncture member 510. When the tube wall L1 of the lymph vessel L is deformed, the outer diameter of the lymph vessel L is widened at the insertion target position b where the needle tip 511 of the puncture member 510 is inserted in the tube wall L1. By puncturing the puncture member 510 into the lymphatic vessel L in this state, it is possible to suitably prevent the needle tip 511 of the puncture member 510 from penetrating the lymphatic vessel L.

  In addition, since the needle tip 511 of the puncture member 510 can be inserted while the insertion target position b is captured by the action of the suction pressure, the lymphatic vessel L is prevented from being collapsed or displaced from the insertion target position b. The Further, since puncture is performed in a state where the periphery of the bulging portion (lifted portion) L2 of the tube wall L1 is covered and protected by the outer cylinder 530, the puncture site t formed by puncture is immediately outside the outer cylinder 530. It becomes possible to protect with. As a result, the puncture site t can be kept clean, and it is possible to prevent the puncture site t and its surrounding sites from being damaged due to the influence of the surrounding environment during the procedure.

  As shown in FIG. 9B, when the negative pressure is generated in the space portion g, the pushing portion 522 of the pusher 520 disposed on the distal end side of the valve body 542 causes the valve body 542 to slide. A through hole 523 that penetrates in the axial direction is formed so that the accompanying suction action is not hindered.

  The negative pressure generator 540 is made of an elastically deformable resin material so that it can slide in the lumen 510a of the puncture member 510 while maintaining airtightness with the inner surface of the puncture member 510. It is preferable to do. Examples of the resin material include natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene butadiene rubber, styrene ethylene butylene styrene rubber, ethylene propylene rubber, acrylonitrile butadiene rubber, fluorine rubber, urethane rubber, polysulfide rubber, chlorinated butyl rubber, Silicone rubber or the like can be used.

  Next, a usage example of the medical device according to the present embodiment will be described.

  In the method for treating lymphedema of the medical device according to this embodiment, referring to FIG. 4, the first indwelling step (S13) and the first connecting step (S14) are different from the method for treating lymphedema of the embodiment described above. To do. Since other processes are the same as those in the above-described embodiment, description thereof will be omitted.

  The first indwelling step (S13) can be performed using the medical instrument 500.

  In starting the first indwelling step (S13), as shown in FIGS. 7 and 8, the medical device 500 includes a first catheter part 110a, a puncture member 510, a pusher 520, an outer cylinder 530, and a negative pressure generating part 540. Each of the above is prepared in an assembled state.

  Next, as shown in FIG. 9A, the distal end portion of the outer cylinder 530 is in contact with the tube wall L 1 of the lymphatic vessel L, and the space g is formed by the outer cylinder 530.

  Next, as shown in FIG. 9B, the negative pressure generating part 540 of the medical instrument 500 is moved to the proximal end side to generate a negative pressure in the space g. By this operation, a part of the tube wall L1 of the lymph vessel L is deformed to the puncture member 510 side, and a bulge portion L2 is formed in the tube wall L1 of the lymph vessel L.

  Next, as shown in FIG. 10A, the puncture member 510 is moved to the distal end side, and the needle tip 511 is punctured into the bulging portion L2 of the lymph vessel L. A puncture site (perforation) t is formed in the tube wall L1 by penetrating the needle tip 511 with respect to the tube wall L1.

  Next, as shown in FIG. 10B, the first catheter portion 110a is pushed toward the distal end side by moving the pusher 520 toward the distal end side. By this operation, the first catheter part 110a is moved to the inside of the puncture site t. Further, at this time, the removal preventing portion 113a of the first catheter portion 110a is arranged inside the lymphatic vessel L. Thereafter, the first catheter portion 110a is released from the puncture member 510 by moving the pusher 520 to the distal end side while moving the puncture member 510 to the proximal end side. As shown in FIG. 11 (A), the first catheter portion 110a has a distal end portion inserted into the lumen of the lymph vessel L and a proximal end portion exposed from the lumen of the lymph vessel L. In the state, it is placed in the lymphatic vessel L.

  Next, a 1st connection process (S14) is performed.

  In the first connection step (S14), as shown in FIG. 11B, the first end portion 310a is connected to the first catheter portion 110a. Thereby, the 1st catheter part 110a and the tube member 300a are connected fluid-tightly.

  Also in the medical device including the medical instrument 500 according to the second embodiment, the same effects as those of the first embodiment described above are exhibited.

  The medical device is deformed so that the puncture member 510 that can puncture the lymph vessel L and the tube wall L1 of the lymph vessel L approach the puncture member 510 side when the puncture member 510 is punctured into the lymph vessel L. And a negative pressure generator 540 that generates a negative pressure for generating the negative pressure. The negative pressure generator 540 prevents the lymph vessel L from being crushed by deforming the tube wall L1 of the lymph vessel L so as to approach the puncture member 510 side. For this reason, the puncture member 510 can be punctured into the lymph vessel L relatively easily. Further, it is preferable that the puncture member 510 penetrates the lymph vessel L by puncturing the puncture member 510 into the tube wall L1 of the lymph vessel L in a state where the tube wall L1 of the lymph vessel L is deformed to the puncture member 510 side. Can be prevented.

  In addition, since the first catheter portion 110a has a removal prevention portion 113a that prevents the first catheter portion 110a from coming out of the lymph vessel L in a state where it is placed in the lymph vessel L, the first catheter portion 110a is placed in the lymph vessel L. The maintained state can be stably maintained.

  As mentioned above, although the medical device which concerns on this invention was demonstrated through embodiment, this invention is not limited only to the structure demonstrated in embodiment, It can change suitably based on description of a claim. is there.

  For example, the pumping unit is not limited to the configuration including the peristaltic pump mechanism as long as the body fluid can be pumped, and a known pumping device can be used.

  In addition, when a body fluid (lymph fluid) is sent from a plurality of first body lumens (lymph vessels) to a second body lumen (vein), the tube member branches the body fluid flow path, and the branched ends thereof. It is good also as a structure provided with a some 1st edge part in a part. In this case, the medical device may be configured to include any one of a plurality of first indwelling needles or a plurality of medical instruments for indwelling the first catheter portion in the plurality of first biological lumens. It is good also as a structure provided with both a needle | hook and a medical device.

  Moreover, although the negative pressure generation part which concerns on 2nd Embodiment was comprised with the piston, as long as it can generate | occur | produce the negative pressure for deforming the tube wall of a 1st biological lumen to the puncture member side However, the present invention is not limited to this.

  In addition, the structure of each part of the medical device described in the above-described embodiment, the arrangement of members, and the like can be changed as appropriate. Omission of use of the additional members described in the drawings, use of other additional members Etc. can be appropriately performed.

10 medical devices,
100 first indwelling needle,
110 first catheter part,
111 sheath,
112 catheter hub,
120 inner needle,
130 inner needle hub,
140 gripping part,
200 second indwelling needle,
210 Second catheter part,
211 sheath,
212 catheter hub,
220 inner needle,
230 inner needle hub,
240 gripping part,
300 tube members,
310 first end,
320 second end,
400 pump (pumping part),
500 medical devices,
510 puncture member,
520 pusher,
530 outer cylinder,
540 negative pressure generator,
110a first catheter part,
113a prevention part,
300a tube member,
310a first end,
L lymphatic vessel (first biological lumen),
L1 pipe wall,
P vein (second biological lumen).

Claims (6)

A first end connected to the first biological lumen;
A tube member comprising: a second end connected to the second biological lumen;
A medical device comprising: a pumping unit that pumps body fluid in the first biological lumen to the second biological lumen.   2. The medical device according to claim 1, wherein the pumping unit includes a peristaltic pump mechanism that swings the tube member to pump body fluid in the first living body lumen to the second living body lumen. A first catheter portion connecting the first biological lumen and the first end of the tube member in a state of being placed in the first biological lumen;
A second catheter portion connecting the second biological lumen and the second end of the tube member in a state of being placed in the second biological lumen;
The medical device according to claim 1, further comprising: A first indwelling needle comprising: the first catheter part; and an inner needle that is punctured into the first living body lumen in a state of being disposed in the lumen of the first catheter part;
A second indwelling needle comprising: the second catheter portion; and an inner needle that is punctured into the second living body lumen in a state of being disposed in the lumen of the second catheter portion;
The medical device according to claim 3. A puncture member capable of puncturing the first biological lumen;
A negative pressure generating unit that generates a negative pressure for deforming the tube wall of the first biological lumen so as to approach the puncture member when the puncture member is punctured into the first biological lumen;
The medical device according to claim 3 or claim 4, comprising:   6. The device according to claim 3, wherein the first catheter unit has a removal prevention unit that prevents the first catheter unit from coming out of the first biological lumen in a state where the first catheter unit is indwelled in the first biological lumen. Medical device.